A System In Need of Repair - Medical Device Regulation: The Example of Latex Medical Gloves

Colleen M. Baker

Synesis: A Journal of Science, Technology, Ethics, and Policy 2013; 4: G32-39

The process of regulating medical devices in the United States was developed and implemented 37 years ago and is currently in need of an overhaul. It has been recommended that a new integrated regulatory framework be established with a clear focus on safety, from the initiation of the approval process through the lifetime or existence of the medical product. Currently, there are numerous safety concerns within the system itself, from the premarket approval to postmarket surveillance issues, as well as questionable agency follow-through once a safety concern has been identified. The overall lack of regulatory response regarding latex medical gloves, for two decades, serves as an eye-opening example of a flawed system long in need of repair, and is herein addressed in detail, with emphasis upon, extant and continued areas in need of systematic remediation.


Keywords: medical device, policy, regulation, latex allergy